Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-27 @ 11:43 AM
Study NCT ID:
NCT06124092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Children After Hospitalization in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}, {'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 690}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Describe families' healthcare requirements throughout their recovery process after PICU.", 'timeFrame': 'Until 36 months post PICU discharge', 'description': 'Descrie the variety of healthcare professional and medical required post PICU hospitalization.'}], 'primaryOutcomes': [{'measure': 'Identify risk factors of PICS-p at 2 months post-PICU', 'timeFrame': '2 months after PICU discharge', 'description': 'Identification of modifiable and non-modifiable risk factors'}, {'measure': 'Develop and validate a model predictive of PICS-p 2 months post PICU', 'timeFrame': '2 months after PICU discharge', 'description': 'The model will allow detection at PICU discharge of children in need of post-PICU follow-up'}], 'secondaryOutcomes': [{'measure': 'Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU', 'timeFrame': 'At 2 months, 12, 18 months and 36 months post PICU discharge', 'description': 'Identify which domain gets impacted and when during the course of the follow-up'}, {'measure': 'Uncover additional post-PICU morbidities not detected within the framework of PICS-p.', 'timeFrame': 'Until 36 months post PICU discharge', 'description': 'Detection of morbidities through the medical provider interview that are not included in the current framework.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Intensive Care Unit', 'PICU'], 'conditions': ['Renal Disease', 'Liver Diseases', 'Heart Diseases', 'Trauma Injury', 'Sepsis', 'Septic Shock', 'Pneumonia', 'Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p).\n\nIt is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.', 'detailedDescription': 'The Pediatric Post-Intensive Care Syndrome (PICS-p) is a newly developed conceptual framework that incorporates the constellation of morbidities that are increasingly recognized to affect children and their families after a critical illness. Experts define PICS-p as a new or worsening impairment in any of the following 5 domains of child health: physical, cognitive, emotional, social, or family.\n\nIn contrast to well established follow-up programs in adults, there is currently a lack of systematic follow-up of PICU survivors which prevents both the recognition and management of PICS-p. The absence of granular, empirical data on the recovery of PICU children impedes both the identification and management of PICS-p.\n\nThis project is a prospective Canadian multicenter cohort study to identify risk factors of PICS-p, develop and validate a predictive model for PICS-p to detect at-risk children, characterize each domain of PICS-p over two years post critical illness and uncover additional morbidities that are not captured using the current PICS-p framework. This study will provide granular, empirical data on which to build developmentally appropriate and tailored screening, management, and intervention programs during and after PICU to improve the global recovery of critically ill children and their family.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient admitted to Pediatric Intensive Care Unit for 96 hours or more will be included in the study unless they age a gestionnal age \\<37 weeks or are over 18 years-old or were admitted to PICu for congenital heart surgery (as they are followed in neuro-cardiac clinic) and for whom the life expectancy is less than 1 year.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ≤18yo hospitalized in PICU for ≥96 hours\n\nExclusion Criteria:\n\n1. gestational age \\<37 weeks or age \\>18 years at PICU entry;\n2. admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);\n3. anticipated life expectancy \\<1year (e.g., active do not resuscitate status).'}, 'identificationModule': {'nctId': 'NCT06124092', 'acronym': 'APCI', 'briefTitle': 'Outcomes of Children After Hospitalization in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'After Pediatric Critical Illness (APCI)', 'orgStudyIdInfo': {'id': 'CHUSJ MP-21-2023-5097'}}, 'armsInterventionsModule': {'interventions': [{'name': 'neurocognitive tests', 'type': 'OTHER', 'otherNames': ['Quality of life'], 'description': "Cohort study: all parents and participants will have questionnaires to complete, based on participant's age."}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'contacts': [{'name': 'Laurie Lee, MD', 'role': 'CONTACT', 'email': 'Laurie.Lee@albertahealthservices.ca'}], 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Colombia', 'country': 'Canada', 'contacts': [{'name': 'Jenny Retallack, MD', 'role': 'CONTACT', 'email': 'jretallack@cw.bc.ca'}], 'facility': 'BC Children Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Karen Choong, MD', 'role': 'CONTACT', 'email': 'choongk@mcmaster.ca'}], 'facility': "McMaster Children's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Dayre McNally, MD', 'role': 'CONTACT', 'email': 'dmcnally@cheo.on.ca'}], 'facility': 'Childrens Hospital of Eastern Ontario', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Nicole McKinnon', 'role': 'CONTACT', 'email': 'nicole.mckinnon@sickkids.ca'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Nadia Roumeliotis, MD', 'role': 'CONTACT', 'email': 'nadezhda.roumeliotis.med@ssss.gouv.qc.ca', 'phone': '514-345-4931', 'phoneExt': '7177'}], 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Patricia Fontela, MD', 'role': 'CONTACT', 'email': 'patricia.fontela@mcgill.ca'}], 'facility': 'Montreal Children Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1J 3H5', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Jean-Sébastien Tremblay-Roy, MD', 'role': 'CONTACT', 'email': 'jean-sebastien.tremblay-roy@usherbrooke.ca', 'phone': '819-346-1100', 'phoneExt': '70188'}], 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'centralContacts': [{'name': 'Geneviève Du Pont-Tibodeau, MD', 'role': 'CONTACT', 'email': 'genevieve.du.pont-thibodeau.med@ssss.gouv.qc.ca', 'phone': '514-345-4931', 'phoneExt': '5553'}, {'name': 'Laurence Ducharme-Crevier, MD', 'role': 'CONTACT', 'email': 'laurence.ducharme.crevier.med@ssss.gouv.qc.ca', 'phone': '514-345-4931', 'phoneExt': '4118'}], 'overallOfficials': [{'name': 'Geneviève Du Pont-Thibodeau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Justine's Hospital"}, {'name': 'Laurence Cucharme-Crevier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Justine's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Genevieve Du Pont-Thibodeau', 'investigatorAffiliation': "St. Justine's Hospital"}}}}